Cholecalciferol EP Impurity D CAS 22350-43-2

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.22350-43-2
Molecular FormulaC27H44O
Molecular Weight384.64 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cholecalciferol EP Impurity D CAS 22350-43-2 chemical structure

Description

As a certified reference material (CRM), Cholecalciferol EP Impurity D meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

CATO supplies Cholecalciferol EP Impurity D (CAS 22350-43-2), a pharmacopoeial impurity reference standard (molecular formula C27H44O, MW 384.64 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, a hydroxyl group, an ether linkage, Cholecalciferol EP Impurity D is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 384.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Physical & Chemical Properties

Molecular FormulaC27H44O
Molecular Weight384.64 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>90%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1963

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